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Improved glycaemic control with BIAsp 30 in insulin-naïve type 2 diabetes patients inadequately controlled on oral antidiabetics: subgroup analysis from the IMPROVE study.
Curr Med Res Opin 2009; 25(11):2643-54CM

Abstract

OBJECTIVE

The aim of this subanalysis of the IMPROVE study was to evaluate the safety and effectiveness of initiating biphasic insulin aspart 30/70 (BIAsp 30) in type 2 diabetes patients uncontrolled on oral antidiabetic drugs (OADs).

METHODS

IMPROVE is a 26-week, open-label, non-randomised, international observational study in type 2 diabetes patients prescribed BIAsp 30 in routine clinical practice. The total cohort comprised 52 419 patients from various pre-study therapies. Here results from the subgroup of previously insulin-naïve patients are reported. Changes in glycated haemoglobin (HbA(1c)), fasting blood glucose (FBG), postprandial blood glucose (PPBG), weight, dose, proportion of patients achieving HbA(1c) < 7.0%, and rates of major and minor hypoglycaemic events were recorded. Treatment satisfaction was assessed using a validated questionnaire.

RESULTS

A total of 29 160 insulin-naïve patients were included; mean age 55.6 years, diabetes duration 7.3 years, baseline HbA(1c) 9.24%. Significant reductions were seen for HbA(1c) (-2.12%; p < 0.0001), FBG (-4.07 mmol/L; p < 0.0001) and PPBG after all meals (mean: -5.27 mmol/L; p < 0.0001); 39.2% of patients achieved HbA(1c) < 7.0% without hypoglycaemia. Better glycaemic control was seen in patients treated with BIAsp 30 twice-daily (BID) both at baseline and final visit, or BID at baseline and three-times daily at final visit, compared with other regimens. The rate of major hypoglycaemic events decreased significantly, while the rate of minor hypoglycaemic events increased. Better glycaemic control and a lower rate of minor hypoglycaemia were observed in patients using BIAsp 30 without OADs than with OADs. There was no clinically relevant change in weight (-0.07 kg; p < 0.0001). At final visit, 59.7% of patients were extremely/very satisfied with treatment, compared with 10.2% at baseline.

CONCLUSIONS

This open-label, non-randomised, observational study demonstrated that initiating insulin therapy with BIAsp 30 significantly improved glycaemic control in insulin-naïve patients previously poorly controlled on OADs. The rate of major hypoglycaemia was reduced and treatment satisfaction increased after initiation of BIAsp 30. Furthermore, better glycaemic control was achieved with BIAsp 30 without OAD compared to with OAD.

Authors+Show Affiliations

China-Japan Friendship Hospital, Beijing, China.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Evaluation Study
Journal Article
Multicenter Study
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

19751116

Citation

Wenying, Yang, et al. "Improved Glycaemic Control With BIAsp 30 in Insulin-naïve Type 2 Diabetes Patients Inadequately Controlled On Oral Antidiabetics: Subgroup Analysis From the IMPROVE Study." Current Medical Research and Opinion, vol. 25, no. 11, 2009, pp. 2643-54.
Wenying Y, Benroubi M, Borzi V, et al. Improved glycaemic control with BIAsp 30 in insulin-naïve type 2 diabetes patients inadequately controlled on oral antidiabetics: subgroup analysis from the IMPROVE study. Curr Med Res Opin. 2009;25(11):2643-54.
Wenying, Y., Benroubi, M., Borzi, V., Gumprecht, J., Kawamori, R., Shaban, J., ... Valensi, P. (2009). Improved glycaemic control with BIAsp 30 in insulin-naïve type 2 diabetes patients inadequately controlled on oral antidiabetics: subgroup analysis from the IMPROVE study. Current Medical Research and Opinion, 25(11), pp. 2643-54. doi:10.1185/03007990903276745.
Wenying Y, et al. Improved Glycaemic Control With BIAsp 30 in Insulin-naïve Type 2 Diabetes Patients Inadequately Controlled On Oral Antidiabetics: Subgroup Analysis From the IMPROVE Study. Curr Med Res Opin. 2009;25(11):2643-54. PubMed PMID: 19751116.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Improved glycaemic control with BIAsp 30 in insulin-naïve type 2 diabetes patients inadequately controlled on oral antidiabetics: subgroup analysis from the IMPROVE study. AU - Wenying,Yang, AU - Benroubi,Marian, AU - Borzi,Vito, AU - Gumprecht,Janusz, AU - Kawamori,Ryuzo, AU - Shaban,Joseph, AU - Shah,Siddharth, AU - Shestakova,Marina, AU - Ligthelm,Robert, AU - Valensi,Paul, AU - ,, PY - 2009/9/16/entrez PY - 2009/9/16/pubmed PY - 2009/12/30/medline SP - 2643 EP - 54 JF - Current medical research and opinion JO - Curr Med Res Opin VL - 25 IS - 11 N2 - OBJECTIVE: The aim of this subanalysis of the IMPROVE study was to evaluate the safety and effectiveness of initiating biphasic insulin aspart 30/70 (BIAsp 30) in type 2 diabetes patients uncontrolled on oral antidiabetic drugs (OADs). METHODS: IMPROVE is a 26-week, open-label, non-randomised, international observational study in type 2 diabetes patients prescribed BIAsp 30 in routine clinical practice. The total cohort comprised 52 419 patients from various pre-study therapies. Here results from the subgroup of previously insulin-naïve patients are reported. Changes in glycated haemoglobin (HbA(1c)), fasting blood glucose (FBG), postprandial blood glucose (PPBG), weight, dose, proportion of patients achieving HbA(1c) < 7.0%, and rates of major and minor hypoglycaemic events were recorded. Treatment satisfaction was assessed using a validated questionnaire. RESULTS: A total of 29 160 insulin-naïve patients were included; mean age 55.6 years, diabetes duration 7.3 years, baseline HbA(1c) 9.24%. Significant reductions were seen for HbA(1c) (-2.12%; p < 0.0001), FBG (-4.07 mmol/L; p < 0.0001) and PPBG after all meals (mean: -5.27 mmol/L; p < 0.0001); 39.2% of patients achieved HbA(1c) < 7.0% without hypoglycaemia. Better glycaemic control was seen in patients treated with BIAsp 30 twice-daily (BID) both at baseline and final visit, or BID at baseline and three-times daily at final visit, compared with other regimens. The rate of major hypoglycaemic events decreased significantly, while the rate of minor hypoglycaemic events increased. Better glycaemic control and a lower rate of minor hypoglycaemia were observed in patients using BIAsp 30 without OADs than with OADs. There was no clinically relevant change in weight (-0.07 kg; p < 0.0001). At final visit, 59.7% of patients were extremely/very satisfied with treatment, compared with 10.2% at baseline. CONCLUSIONS: This open-label, non-randomised, observational study demonstrated that initiating insulin therapy with BIAsp 30 significantly improved glycaemic control in insulin-naïve patients previously poorly controlled on OADs. The rate of major hypoglycaemia was reduced and treatment satisfaction increased after initiation of BIAsp 30. Furthermore, better glycaemic control was achieved with BIAsp 30 without OAD compared to with OAD. SN - 1473-4877 UR - https://www.unboundmedicine.com/medline/citation/19751116/Improved_glycaemic_control_with_BIAsp_30_in_insulin_naïve_type_2_diabetes_patients_inadequately_controlled_on_oral_antidiabetics:_subgroup_analysis_from_the_IMPROVE_study_ L2 - http://www.tandfonline.com/doi/full/10.1185/03007990903276745 DB - PRIME DP - Unbound Medicine ER -